Sirolimus-eluting coronary stents: a review

The sirolimus-eluting coronary stent received CE Mark approval in Europe in April 2002. In the US, FDA approval followed in April 2003. Since the preliminary results from the First-in-Man feasibility study were presented, several randomized, controlled trials have documented the profound antiproliferative effects of sirolimus, a macrolide antibiotic and potent cytostatic inhibitor of smooth muscle cell proliferation. Subsequently, the body of clinical evidence was increased by the second wave of evidence from trials in more complex lesions (such as in-stent restenosis, small vessels, chronic total occlusions) and “high-risk” patients such as those with diabetes. More recently we have had the opportunity to compare the two commercially available drug-eluting stents following the presentation of data from six head-to-head trials. As a result of numerous single and multi-center, national and international studies in which the safety and efficacy of sirolimus-eluting coronary stents have been subjected to close scrutiny, the global interventional cardiology community now has a wealth of evidence in support of the use of this technology resulting in dramatically improved patient outcomes after percutaneous intervention

Renal Sympathetic Denervation and Quality of Life

ABSTRACTBackgroundRenal sympathetic denervation (RSD) is a promising strategy in the treatment of resistant hypertension. No studies have assessed the effect of RSD on quality of life in our country, which was the aim of this study.MethodsThe EuroQol5 Dimensions questionnaire (EQ5D5L) was chosen to evaluate quality of life in 10 patients undergoing RSD, and it was applied before and 3 months after the procedure.ResultsMean age was 47.3 ± 12 years and 90% of the patients were female. Baseline blood pressure was 187 ± 37.5/104 ± 18.5mmHg and the number of antihypertensive drugs was 7.6 ± 1.3. Before the procedure, the value assigned to health status was 37.5 ± 22.7, increasing at 3 months to 70.5 ± 20.9 (P = 0.01). In the follow-up, in addition to a decrease in the number of antihypertensive drugs (7.6 ± 1.3 vs. 6 ± 2.2; P = 0.05), a trend towards reduced levels of systolic blood pressure (187 ± 36mmHg vs 170 ± 44mmHg; P = 0.10) and diastolic blood pressure (104 ± 18mmHg vs 98 ± 20mmHg; P = 0.20) was observed. Health status improvement resulted from a reduction of problems related to mobility, usual activities, pain/discomfort and anxiety/depression. The magnitude of blood pressure reduction was not associated with improved quality in all of the patients. On the other hand, those who had a decrease in the number of antihypertensive drugs reported a better health status.ConclusionsPatients with resistant hypertension have poor health status scores. RSD improved quality of life in most patients. Further studies are required to confirm consistent benefits

Evaluation of Four-Year Coronary Artery Response After Sirolimus-Eluting Stent Implantation Using Serial Quantitative Intravascular Ultrasound and Computer-Assisted Grayscale Value Analysis for Plaque Composition in Event-Free Patients

ObjectivesThis study sought to evaluate the long-term arterial response after sirolimus-eluting stent implantation.BackgroundSirolimus-eluting stents are effective in inhibiting neointimal hyperplasia without affecting plaque volume behind the stent struts at six months.MethodsSerial quantitative intravascular ultrasound and computer-assisted grayscale value analysis over four years were performed in 23 event-free patients treated with sirolimus-eluting stents.ResultsIn the first two years, the mean plaque volume (155.5 ± 42.8 mm3post-procedure and 156.8 ± 57.7 mm3at two years, p = 0.86) and plaque compositional change expressed as mean percent hypoechogenic tissue of the plaque behind the stent struts (78.9 ± 8.6% post-procedure and 78.2 ± 8.9% at two years, p = 0.67) did not significantly change. However, significant plaque shrinking (change in plaque volume = −18.4 mm3, p = 0.02) with an increase in plaque echogenicity (change in percent hypoechogenic tissue = −7.8%, p < 0.0001) was observed between two and four years. The mean neointimal volume increased over four years from 0 to 8.4 ± 5.8 mm3(p < 0.0001). However, no further statistically significant change occurred between two and four years (7.0 ± 6.7 mm3vs. 8.4 ± 5.8 mm3, p = 0.25).ConclusionsBetween two and four years after sirolimus-eluting stent implantation, peri-stent tissue shrank with a concomitant increase in echogenicity. These intravascular ultrasound findings suggest that late chronic artery responses may evolve for up to four years after sirolimus-eluting stent implantation. In addition, the fact that the neointima does not significantly change from two to four years may suggest that the biological phenomenon of a delayed healing response has begun to subside

Denervação simpática renal em pacientes com cardiodesfibrilador implantável e tempestade elétrica

ResumoIntroduçãoCardiodesfibriladores implantáveis (CDIs) são geralmente indicados para pacientes com arritmias malignas considerados de alto risco. A hiperatividade simpática desempenha um papel crítico no desenvolvimento, na manutenção e no agravamento de arritmias ventriculares. Novas opções de tratamento nessa população representam uma necessidade clínica. Nosso objetivo foi relatar os resultados de pacientes com CDIs e tempestade elétrica submetidos à denervação simpática renal para controle da arritmia.MétodosOito pacientes com CDIs internados por tempestade elétrica refratária ao tratamento médico otimizado foram submetidos à denervação simpática renal. Condições subjacentes foram: doença de Chagas (n = 6), cardiomiopatia dilatada não isquêmica (n = 1) e cardiomiopatia isquêmica (n = 1). As informações sobre o número de taquicardias ventriculares/fibrilações ventriculares e episódios de terapias antitaquicardia na última semana pré‐procedimento e nos 30 dias pós‐tratamento foram obtidas por meio de interrogação dos CDIs.ResultadosAs medianas dos episódios de taquicardias ventriculares/fibrilações ventriculares, sobre‐estimulação e choques na semana que antecedeu a denervação simpática renal foram de 29 (9 a 106), 23 (2 a 94) e 7,5 (1 a 88), sendo significativamente reduzidas para 0 (0 a 12), 0 (0 a 30) e 0 (0 a 1), respectivamente, 1 mês após o procedimento (p = 0,002; p = 0,01; p = 0,003). Nenhum paciente morreu durante o acompanhamento. Não ocorreram complicações maiores relacionadas ao procedimento.ConclusõesEm pacientes com CDIs e tempestade elétrica refratária ao tratamento médico otimizado, a denervação simpática renal reduziu significativamente a carga de arritmia e, consequentemente, as sobre‐estimulações e os choques. Ensaios clínicos randomizados, no contexto de denervação simpática renal para controle de arritmias cardíacas refratárias, são necessários para trazer maior robustez aos nossos achados.AbstractBackgroundImplantable cardioverter‐defibrillators (ICDs) are usually indicated for patients with malignant arrhythmias considered as high risk. Sympathetic hyperactivity plays a critical role in the development, maintenance, and worsening of ventricular arrhythmias. New treatment options in this population represent a clinical necessity. This study's objective was to report the outcomes of patients with ICDs and electrical storm submitted to renal sympathetic denervation for arrhythmia control.MethodsEight patients with ICDs admitted for electrical storm refractory to optimal medical therapy underwent renal sympathetic denervation. Underlying diseases included Chagas disease (n = 6), non‐ischemic dilated cardiomyopathy (n = 1), and ischemic cardiomyopathy (n = 1). Information on the number of episodes of ventricular tachycardia/ventricular fibrillation and antitachycardia therapies in the week before the procedure and 30 days after treatment were obtained through interrogation of the ICDs.ResultsThe median numbers of episodes of ventricular tachycardia/ventricular fibrillation, antitachycardia pacing, and shocks in the week before renal sympathetic denervation were 29 (9 to 106), 23 (2 to 94), and 7.5 (1 to 88), and significantly reduced to 0 (0 to 12), 0 (0 to 30), and 0 (0 to 1), respectively, 1 month after the procedure (p = 0.002; p = 0.01; p = 0.003, respectively). No patients died during follow‐up. There were no major complications related to the procedure.ConclusionsIn patients with ICDs and electrical storm refractory to optimal medical treatment, renal sympathetic denervation significantly reduced arrhythmia load and, consequently, antitachycardia pacing and shocks. Randomized clinical trials in the context of renal sympathetic denervation to control refractory cardiac arrhythmias are needed to further support these findings